National Institute Of Health And Clinical Excellence Research Articles

Evolution of the evidence on the effectiveness and cost-effectiveness of acetylcholinesterase inhibitors and memantine for Alzheimer's disease: systematic review and economic model†

in 2007 the National Institute of Health and Clinical Excellence (NICE) restricted the use of acetylcholinesterase inhibitors and memantine. we conducted a health technology assessment (HTA) of the effectiveness and cost-effectiveness of donepezil, galantamine, rivastigmine and memantine for the treatment of AD to re-consider and up-date the evidence base used to inform the 2007 NICE decision. The systematic review of effectiveness targeted randomised controlled trials. A comprehensive search, including MEDLINE, Embase and the Cochrane Library, was conducted from January 2004 to March 2010. All key review steps were done by two reviewers. Random effects meta-analysis was conducted. The cost-effectiveness was assessed using a cohort-based model with three health states: pre-institutionalised, institutionalised and dead. The perspective was NHS and Personal Social Services and the cost year 2009. confidence about the size and statistical significance of the estimates of effect of galantamine, rivastigmine and memantine improved on function and global impact in particular. Cost-effectiveness also changed. For donepezil, galantamine and rivastigmine, the incremental cost per quality-adjusted life year (QALY) in 2004 was above £50,000; in 2010 the same drugs 'dominated' best supportive care (improved clinical outcome at reduced cost). This was primarily because of changes in the modelled costs of introducing the drugs. For memantine, the cost-effectiveness also improved from a range of £37-53,000 per QALY gained to a base-case of £32,000. there has been a change in the evidence base between 2004 and 2010 consistent with the change in NICE guidance. Further evolution in cost-effectiveness estimates is possible particularly if there are changes in drug prices.

Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008

ObjectiveTo survey vitamin K deficiency bleeding (VKDB) and document vitamin K (VK) prophylaxis practice, and compare with findings predating withdrawal of Konakion Neonatal and guidance from the National Institute of...

Screening for alcohol use disorders in HIV patients

Many chronic health conditions have been linked to alcohol consumption, as well as excess morbidity, mortality and an increased financial burden on the National Health Service (NHS). The British HIV Association (BHIVA) recommends that HIV patients be asked about alcohol due to its effect on adherence to antiretroviral therapy. National Institute of Health and Clinical Excellence (NICE) guidelines recommend screening for alcohol use disorders in patients attending genitourinary medicine (GUM) clinics. In this study we looked at the use of a screening tool for alcohol use disorders in HIV patients in a metropolitan city. We assessed HIV patients over a 6‐month period for alcohol use disorders using the AUDIT‐C questionnaire. Patients with a score >4 were identified as higher risk and provided with brief advice about alcohol and offered written information and support. Demographic data was collected along with hepatitis B and C status, information on sexually transmitted infection (STI) testing and diagnosis. 352 patients were reviewed with a mean age of 41. 297 (84.4%) patients were male, 235 (66.8%) were white British and 251 (71.3%) were men who have sex with men (MSM). 277 (78.7%) patients were on antiretroviral therapy with 254 (91.7%) of these having an undetectable viral load. Alcohol use disorders were assessed using the AUDIT‐C score in 332 (94.3%) patients with no patient declining assessment. 166 (50%) patients had an AUDIT‐C score >4 signifying higher risk. Alcohol advice was provided to 161 (97%) of these patients and a Drink Smart guide offering advice on alcohol self help offered to 103 (64%) patients and accepted by 45 (43.7%). An opportunistic STI screen was offered to 258 (73.3%) patients on that visit in line with best practice guidelines and was accepted by 83 (32.2%). 25 infections were found in 20 patients, of which 13 (65%) had AUDIT‐C scores >4. There were 8 active hepatitis C co‐infected patients of which 3 had an AUDIT‐C score >4 and 12 chronic hepatitis B co‐infected patients with 3 having an AUDIT‐C score >4. Our results show that screening for alcohol use disorders using the AUDIT‐C questionnaire has high acceptability among HIV patients; however the data is biased to Caucasian MSM. Alcohol use has been shown to exacerbate liver damage in patients with chronic hepatitis, increase the likelihood of STI acquisition and compromise immunity. It is therefore important to screen for and quantify alcohol use as part of routine HIV clinical practice.

Caesarean section on maternal request for non-medical reasons: Putting the UK National Institute of Health and Clinical Excellence guidelines in perspective

The past decade has seen an unprecedented rise in the demand for caesarean sections on maternal request (CSMR), in the absence of any medical or obstetric indication. Much of this rise is the result of the perceived myth of safety of caesarean sections and the changing attitudes of society and the medical profession to childbirth. The debate on the medical, ethical and cost implications of rising rates of caesarean section on maternal request have prompted the issuing of numerous guidelines over the past few years, including one by the National Institute of Health and Clinical Excellence (NICE) in the UK. All these guidelines are uniformly less critical of CSMR than guidelines issued even a decade ago, and suggest valid management strategies. In this chapter, I explore the reasons behind the increase in CSMR and review the current published research, including the risks, benefits, controversies, cost and ethics surrounding CSMR. I then discuss various guidelines, putting the NICE guidelines in perspective.

Health-integrated planning at the local level in England: Impediments and opportunities

The project commissioned by the National Institute of Health and Clinical Excellence (NICE) aimed to examine the degree to which UK, mainly English local planning authorities, incorporate health in their land use plans and development decisions. The project involved systematic reviews of evidence together with case studies. The range of performance in relation to health identified in the project shows that best practice in England depends not so much on the planning system per se, as on the leadership, commitment and knowledge of politicians and practitioners involved. The barriers to health integration are organisational and professional silos, ignorance, resources, and reactive planning regime. Clear lessons for research and practice are emerging: first, well attested research evidence is quite scarce, for example in relation to sustainability appraisal and health; second, planning agencies need to forge good partnerships with public health, transport, housing and economic development decision-makers, and develop proactive, healthy plans; the new planning regime and move of the public health function into local authorities in 2013 in England will give policy opportunities for the consideration of health outcomes in planning decisions, and research should in time evaluate if results have been achieved on the ground.

Psychosocial support for people with diabetes: past, present and future

Psychosocial support for people with diabetes: past, present and future

1417PD - Nice Technology Appraisals and the Uptake of Breast Cancer Drugs in the UK

ABSTRACT Background Health technology appraisal (HTA) recommendations from the UK National Institute of Health and Clinical Excellence (NICE) are intended to standardise health care throughout the NHS, and to hasten the uptake of new, more effective medicines that are cost-effective. Although it is compulsory for the NHS to fund drugs recommended by NICE, it is not clear how well NICE guidance is implemented. A number of studies have investigated whether NICE guidance influences UK drug uptake as intended. Most have used sales data, however, this approach has significant limitations. Sales data do not reveal which indication, line of therapy, nor patient sub-group a drug has been used to treat. Many drugs are licensed for multiple indications, and many HTAs only recommend the use of drugs in defined sub-groups, often subsets of the licensed indication. To avoid the limitations of sales data-based analyses, this study used IMS Health's Oncology AnalyzerTM as the primary data source. Oncology AnalyzerTM contains detailed records for a representative sample of patients, allowing analyses to be focussed on the particular indication and treatment criteria specified in NICE HTAs. Methods HTAs for breast cancer drugs appraised by NICE from 2005 to 2008 were analysed. For each HTA, the proportion of the eligible patient sub-group that received the recommended (or not recommended) drugs from Q1 2005 to Q1 2009 was determined. Changes in uptake of the drugs in the relevant patient populations were assessed for the UK, and were also compared to uptake in similar European countries. Results NICE produced 6 HTAs for breast cancer, encompassing 8 drugs, during the period assessed. In 5 out of 6 cases, the publication of an HTA was followed by the recommended change in UK drug uptake. However, when UK uptake of drugs recommended by NICE was compared to uptake of the same drugs in four other European countries (France, Germany, Italy and Spain), the UK ranked at the bottom of the group. Conclusions The NICE HTAs assessed were mostly followed by the intended changes in drug uptake, suggesting they were implemented, at least by some PCTs. Despite this, international comparisons of uptake for these drugs revealed that the UK performed poorly compared to similar European countries. Disclosure D. Bertwistle: This research uses data from the IMS Health data asset, Oncology AnalyzerTM. I am an employee of IMS Health. P. Anderson: This research uses data from the IMS Health data asset, Oncology AnalyzerTM. I am a former employee of IMS Health. All other authors have declared no conflicts of interest.

Group Acupuncture for Osteoarthritis; a Practical Option?

Knee pain due to osteoarthritis is an increasing health problem.1 ,2 Acupuncture is a promising treatment for osteoarthritis that may provide symptom relief without the adverse cardiovascular events associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). When the UK National Institute of Health and Clinical Excellence (NICE) reviewed the evidence for its 2008 osteoarthritis guideline,3 they concluded that it seemed likely that acupuncture can provide some short-term to medium-term relief for some people living with osteoarthritis. However, in contrast with NICE back pain guidance,4 they did not make a positive recommendation for acupuncture. Importantly, as reported in one of the linked papers,5 the approach to the health economic analysis in the NICE osteoarthritis guideline compared verum and sham acupuncture whereas the NICE back pain guideline compared acupuncture with usual care. The Osteoarthritis Research Society International has recommended that ‘acupuncture may be of symptomatic benefit’6 and a subsequent Cochrane review of acupuncture7 concluded that there were small benefits from acupuncture when …

Patterns of adherence to NICE glaucoma guidance in two different service delivery models.

To assess adherence patterns to the UK National Institute of Health and Clinical Excellence (NICE) guidelines on glaucoma management (2009) in a tertiary referral centre shared care setting and in a district general hospital (DGH) setting. We performed a retrospective case note analysis of 200 patients from two centres between January and June 2010. The two centres involved were a consultant-guided teaching hospital optometry-led shared care setting (setting 1) and a consultant-led DGH clinic setting (setting 2). The main outcome measures were compliance with eight of the main NICE guidelines on glaucoma diagnosis and management (2009). Both centres showed good adherence to the guidelines regarding the choice of initial treatment (96% vs 100%, settings 1 and 2, respectively) and arranging appropriate monitoring intervals (92% vs 86%). However, significant differences were seen when assessing whether an optic disc image was obtained at the initial visit (74% vs 10%), whether an appropriate initial assessment was performed (96% vs 58%), whether patients' review interval complied with the NICE guidance regardless of hospital cancellations (92% vs 66%), and whether concordance with medication was checked (88% vs 24%) (settings 1 and 2, respectively, P<0.01-Fisher's exact test). Our study provides evidence to suggest that a hospital-based shared care service with trained optometrists using assessment sheets compares favourably to non-specialist glaucoma care delivered by ophthalmologists.

Guidelines for people not for diseases: the challenges of applying UK clinical guidelines to people with multimorbidity

currently one of the major challenges facing clinical guidelines is multimorbidity. Current guidelines are not designed to consider the cumulative impact of treatment recommendations on people with several conditions, nor to allow comparison of relative benefits or risks. This is despite the fact that multimorbidity is a common phenomenon. to examine the extent to which National Institute of Health and Clinical Excellence (NICE) guidelines address patient comorbidity, patient centred care and patient compliance to treatment recommendations. five NICE clinical guidelines were selected for review (type-2 diabetes mellitus, secondary prevention for people with myocardial infarction, osteoarthritis, chronic obstructive pulmonary disease and depression) as these conditions are common causes of comorbidity and the guidelines had all been produced since 2007. Two authors extracted information from each full guideline and noted the extent to which the guidelines accounted for patient comorbidity, patient centred care and patient compliance. The cumulative recommended treatment, follow-up and self-care regime for two hypothetical patients were then created to illustrate the potential cumulative impact of applying single disease recommendations to people with multimorbidity. comorbidity and patient adherence were inconsistently accounted for in the guidelines, ranging from extensive discussion to none at all. Patient centred care was discussed in generic terms across the guidelines with limited disease-specific recommendations for clinicians. Explicitly following guideline recommendations for our two hypothetical patients would lead to a considerable treatment burden, even when recommendations were followed for mild to moderate conditions. In addition, the follow-up and self-care regime was complex potentially presenting problems for patient compliance. clinical guidelines have played an important role in improving healthcare for people with long-term conditions. However, in people with multimorbidity current guideline recommendations rapidly cumulate to drive polypharmacy, without providing guidance on how best to prioritise recommendations for individuals in whom treatment burden will sometimes be overwhelming.

Physical examination of the newborn: service provision and future planning

It is recommended that a physical examination of the newborn (PEN) is carried out within 72 hours following birth ( National institute of Health and Clinical excellence (NICE), 2006) . Historically, these examinations have been carried out by junior paediatricians or general practitioners (GPs). However, it is now increasingly likely that PEN will be done by midwives and advanced neonatal nurse practitioners (ANNPs) instead. This move has been made to embrace the government ethos for the NHS where midwives and nurses take on extended roles, traditionally carried out by doctors ( Department of Health (DH), 2007 ; DH, 2009 ). There is variation in how maternity services are providing PEN nationally. Locally, we became increasingly aware that there are factors that need to be considered to ensure optimal service provision. This paper describes the models of care that are used by midwives carrying out PEN locally, and highlights the catalysts for change to provide a flexible women-centred, efficient and cost-effective service.

Extracorporeal Carbon Dioxide Removal (ECCO2R) in Respiratory Failure: An Overview, and where Next?

Extracorporeal carbon dioxide removal (ECCO2R) is used to facilitate protective ventilation strategies and to treat severe hypercapnic acidosis that is refractory to mechanical ventilation. There is an increasing amount of interest in the use of ECCO2R but there are no recommendations for its use that take the most recent evidence into account. In 2008, the National Institute of Health and Clinical Excellence (NICE) published guidelines on ‘Arteriovenous Extracorporeal Membrane Carbon Dioxide Removal.’1 However, since that time there have been a number of studies in the area and some significant technological advances including the introduction of commercially available VV-ECCO2R systems. The aim of this article is to provide an overview of ECCO2R, review the literature relating to its use and discuss its future role in the intensive care setting.

NICE: opioids should be first-line for cancer pain

The newly released recommendations for opioids in palliative care from the UK's National Institute of Health and Clinical Excellence (NICE) is the latest in a series of guidelines about the management of severe cancer pain. It is aimed at non-specialist health-care professionals who are initiating strong opioids for adults with advanced and progressive disease. The guidance aims to overcome reluctance from health professionals and patients who are concerned about side-effects of opioids, risk of toxic effects, whether long-term use will lead to tolerance and therefore unmanageable pain, and whether use of opioids will be taken as a signal of end-of-life care.

Effective UK weight management services for adults.

A number of evidence-based weight management interventions are now available with different models and serving different patient/client groups. While positive outcomes are a key to the decision-making process, so too is the information around how these outcomes were achieved, in what population, how transferable the outcomes would be to the population a service would be aiming to cover and at what cost to the service provider and or the individual. This paper examines all the UK interventions with recent peer-reviewed evidence of their effectiveness in 'realistic' settings and cost-effectiveness, in the context of National Institute of Health and Clinical Excellence (NICE) and Scottish Intercollegiate Guideline Network (SIGN) guidelines. It concludes that the evidence-based approaches allow intervention at different stages in the disease process of obesity, which are effective in different settings. Self-referral to commercial agencies, by individuals with relatively low body mass index (BMI) and few medical complications, is a reasonable first step. For more severely obese individuals (e.g. BMI > 35 kg m(-2) ) requiring more medically complicated care, evidence is largely lacking for these services, but the community-based Counterweight Programme is effective and cost-effective in maintaining weight loss >5 kg up to 2 years for 30-40% of attenders. For more complicated and resistant obesity, referral to a secondary care-based service can generate short-term weight loss, but 12-month data are unavailable.

Screening for antenatal psychological distress

Effective psychological screening within the perinatal period has been an increasing priority for maternity services. The screening questions recommended by the National Institute of Health and Clinical Excellence (NICE) guidance for antenatal care (2008) screen only for depression and do not give an indication of severity. This service development looked at staff confidence in psychological assessment after the provision of training. It also used the Hospital Anxiety and Depression Scale (HADS) ( Zigmond and Snaith, 1983 ) as a screening measure for anxiety and depression during the booking interview with a community midwife. It was found that training significantly increased staff confidence in their ability to identify and manage psychological distress. HADS is not validated in perinatal populations; trends suggest prevalence of antenatal anxiety in this sample is equal to that of antenatal depression. The questions sometimes referred to as the ‘Whooley questions’ ( Whooley et al, 1997 ) are identical to the Patient Health Questionnaire (PHQ-2) and will be referred to as such throughout this article. Comparison between the HADS and the PHQ-2 indicated that the latter is less sensitive to anxiety, especially when a woman scores in the borderline ranges.

An agenda for UK clinical pharmacology: UK medicines policy: the role of clinical pharmacologists

Clinical pharmacologists are the only medical specialists whose training focuses specifically on the safe, effective and cost‐effective use of medicines, underpinned by an understanding of drug discovery, drug regulation, pharmacology, translational medicine and the performance of clinical trials. This unique perspective has allowed them to provide expertise and leadership in medicines regulation, medicines policy, health technology assessment and drug pricing. Clinical pharmacologists assisted in the creation of the Committee on Safety of Medicines (now the Commission on Human Medicines), the Yellow Card Scheme, the National Institute of Health and Clinical Excellence (NICE) and related organizations in Scotland and Wales, and contributed to clinical guidelines (through the Scottish Intercollegiate Guidelines Network) and the British National Formulary. Their research work has contributed substantially, through translational medicine and therapeutics, to the development of new medicines and, as a result, creation of health and wealth in the UK. Their work in medicines policy has served to protect patients from harms associated with the use of medicines. A reduction in the number of able junior doctors attracted to a career in clinical pharmacology, a reduction in the number of training posts, and an ageing population of academic trainers, puts the future of the specialty, and its contribution to patient safety and UK wealth creation, at substantial risk. Urgent measures are needed to convince the NHS and government that these essential skills should be protected and nurtured.

NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium

ObjectivesTo compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process...

Improving Compliance with NICE Guidelines on Parkinson's isease: A Quality Improvement Study.

Parkinson's disease can progressively affect daily function and multidisciplinary teamwork is essential to provide high quality care. The National Institute of Health and Clinical Excellence (NICE) issued guidelines regarding diagnosis, follow-up, and multidisciplinary care. This quality improvement project sought to measure and improve the compliance of service provision against the guidelines.In total, 3 audit cycles were completed. Each audit involved reviewing notes of patients attending a Parkinson's disease outpatient clinic against the PD NICE guidelines audit criteria. The first and second audits showed compliance was high for the criteria relating to initial diagnosis and referral but poor for those criteria relating to multidisciplinary referral.A pro forma stamp was recommended to be placed in the notes at each regular Parkinson's outpatient review by a specified date (October 2009), with re-audit occurring in June 2011 as part of the official hospital audit plan.Compliance to the NICE criteria improved to 100% on all criteria measured. However, it was evident from the notes that the pro forma that had been recommended by the previous audit had been in use but was not at present. In fact the pro forma had been so successful that the clinicians had made each of the criteria a routine part of their consultations and so did not need to rely on it.Use of a checklist can have a lasting improvement on compliance with NICE guidelines, even if the intervention itself is transient.

Tracking the impact of research on policy and practice: investigating the feasibility of using citations in clinical guidelines for research evaluation

ObjectivesTo investigate the feasibility of using research papers cited in clinical guidelines as a way to track the impact of particular funding streams or sources.SettingIn recent years, medical research funders...

Are new forms of professionalism emerging in medicine? The case of the implementation of NICE guidelines

Scientific-bureaucratic medicine (SBM) has been the dominant discourse on evidence-based medicine in the English National Health System (NHS). It has being claimed that SBM has led to new forms of medical professionalism with an emphasis on organisational values and the control of autonomy. This paper explores the medical professions’ response to SBM, where SBM is manifested in the form of National Institute of Health and Clinical Excellence (NICE) guidelines. Seventy-four face-to-face informal interviews were carried out with clinicians and managers between 2007 and 2009. Three major themes emerged from the analysis each of which was linked to doctors’ receptiveness to NICE guidelines implementation. The first emphasised organisational values, which accounted for conditional acceptance of NICE guidelines. The second was proactive professionalism or entrepreneurial professionalism, which was linked to the rejection of NICE guidelines and the emergence of alternative forms of introducing new ideas for the expansion of their clinical practice. The third was related to the prominence of clinical autonomy linked with doctors’ resistance to the use of NICE guidelines. It is argued that this evidence does not reflect a significant emergence of new forms of professionalism but the development of multiple occupational identities.